Principal Medical Writer
Vor 2 Tagen
As a Principal Medical Writer (m/w/d), you will - Prepare a variety of clinical regulatory documents as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate. - Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company’s clients. - Be responsible for providing document-specific advice to clients. - Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility. - Project manage the timelines and review cycles of your documents. - Work in the client’s regulatory document management systems. - Relevant professional experience actively writing regulatory documents. - Worked as the lead writer on >5 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications, PSUR or DSUR, PBRER, RMP, or PIP. - Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines. - Ability and willingness to take on any project for which a Lead Writer is needed. - Competency in the use of document management systems and review tools. In addition to having the above writing experience, applicants must have: - Diploma/Master's/Bachelor’s degree in science/pharmacy (Ph.D. not necessary). - Fluent written and spoken English skills. - An appreciation for a well-written document and an eye for details. - Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities. - Flexibility and the ability to stay focused under tight timelines. Remuneration will be relative to the level of experience, with all standard Trilogy benefits. - Submission of documents in English: - Cover letter specifying how you comply with the experience requirements listed below - CV - Trilogy Writing & Consulting complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state/provincial, and local law. We passionately believe in creating a supportive environment in which everyone can grow, flourish, and do their best work.
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Senior/principal Medical Writer
vor 14 Stunden
Frankfurt am Main, Deutschland Trilogy Writing & Consulting VollzeitTrilogy Writing & Consulting is currently looking to hire Senior and Principal Medical Writers (m/w/d) to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. Our...
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(Junior) Medical Writer
Vor 4 Tagen
Frankfurt am Main, Deutschland PINK CARROTS Communications GmbH Vollzeit**THINKING HEALTH DIFFERENTLY** **Über PINK CARROTS** **PINK CARROTS**ist eine inhabergeführte strategisch-kreative Kommunikationsagentur spezialisiert auf Health und Wellbeing. Das Team aus 50 Mitarbeitenden versteht Gesundheit als breites Dach. Und als weites Feld voller Möglichkeiten, um Menschen und Marken zu verbinden. Insight-basiert erarbeiten...
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Senior Medical Writer
Vor 2 Tagen
Frankfurt am Main, Deutschland Trilogy Writing & Consulting GmbH VollzeitAs a Senior Medical Writer (m/w/d), you will: - Prepare a variety of clinical regulatory documents as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate. - Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and...
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Senior Medical Writer, National Healthcare Team
Vor 6 Tagen
Frankfurt am Main, Deutschland Weber Shandwick Vollzeit**Who are we?** **_ Weber Shandwick_** is a leading global communications network - with earned ideas at the core, the agency deploys leading and emerging technologies to inform strategy, develop critical insights and heighten impact across sectors and specialty areas, including brand and B2B marketing, healthcare communications, change management, employee...
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Principal Investigator
vor 2 Wochen
Frankfurt am Main, Deutschland Barrington James VollzeitI’m currently looking to connect with Investigators across Germany who are involved in clinical research and development. This opportunity would suit a qualified medical doctor who holds Approbation and has experience or a strong interest in clinical trials, ideally across Phases I–III and in endocrinology. (Sub-Investigator or Principal Investigator...
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Sr. Medical Writer
Vor 6 Tagen
Frankfurt (Oder), Brandenburg, Deutschland Syneos Health VollzeitSr. Medical Writer (Regulatory)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of...
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Medical Writer
vor 2 Wochen
Frankfurt am Main, Deutschland PINK CARROTS Communications GmbH GWA Vollzeit**DU BEI PINK CARROTS***: - Du arbeitest dich schnell in neue Indikationen ein und berätst Kund*innen auf Augenhöhe. - Du erstellst Konzepte und Inhalte für wissenschaftliche und werbliche Formate (u.a. Folder, eDetailer, Slidedecks, Websites) für Fach - und Laienzielgruppen. - Du besuchst Fachkongresse und übernimmst die Nachberichterstattung. - Du...
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Principal Investigator
vor 2 Wochen
Frankfurt, Deutschland Barrington James VollzeitI’m currently looking to connect with Investigators across Germany who are involved in clinical research and development.This opportunity would suit a qualified medical doctor who holds Approbation and has experience or a strong interest in clinical trials, ideally across Phases I–III and in endocrinology.(Sub-Investigator or Principal Investigator...
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Principal Level Designer
Vor 4 Tagen
Frankfurt am Main, Deutschland Ґанзілла Vollzeit**ABOUT GUNZILLA GAMES**: Founded in 2020, Gunzilla Games is a fresh, independent AAA developer working on its Battle Royale 2.0 Off The Grid in three metropolitan locations: Frankfurt, Germany (HQ); Los Angeles, USA; and Kyiv, Ukraine. The company is helmed by serial entrepreneur CEO, Vlad Korolev and CSO Alexander Zoll. Gunzilla is built on the desire to...
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Intern (M/F/d) Biomedical Evidence Generation
vor 14 Stunden
Frankfurt Am Main, Deutschland Fresenius Medical Care VollzeitYou are interested in the development of person-centered approaches in the context of medical devices and kidney care as well as conceptualizing and running clinical studies? Then join our Biomedical Evidence Generation - Person-Centered Outcomes Research team at Fresenius Medical Care. In this way, you will get a taste of cutting-edge research with a...
